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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name crown and bridge, temporary, resin
510(k) Number K120784
Device Name TUFF-TEMP 2.0
Original Applicant
80 oakland st
watertown,  MA  02472
Original Contact kenneth j berk
Regulation Number872.3770
Classification Product Code
Date Received03/15/2012
Decision Date 06/08/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No